Lavender Aromatherapy for Sleep in Hospitalized Adult Patients

Not Applicable

Terminated

• Conditions: Hospitalization; Sleep
• Interventions: Other: Grapeseed Oil; Other: lavender oil

• Registration Number: NCT04648215
• Lead Sponsor: Northwell Health

Brief Summary

This feasibility study's aim is to determine the effectiveness of lavender oil aromatherapy on quality and duration of sleep in hospitalized adult patients

Detailed Description

Hospitalized patients on a medical unit will be randomly assigned to one of three groups of 36 patients: Intervention (Lavender oil), Placebo Intervention (Grapeseed Oil), or Control (Standard of Care). Following a determination of meeting inclusion criteria on admission and completing informed consent, subjects will be randomized to one of three groups on admission. This is a 4 day study with pre- intervention (baseline) sleep data on quality and duration of sleep using the Verrans \& Halpern- Snyder Sleep Scale collected on Day 2, following admission day.

For the intervention, indirect aromatherapy, a 2x2 gauze with 2 drops of either oil (lavender or grapeseed is pinned it to the subjects' nightgown (right scapula area) for two sequential nights (Time 1 and Time 2) (Day 2 and 3) and removed in the morning after 10 hours . Sleep Quality and Duration are then measured in the morning, Time 1 and Time 2, (Day 3 and Day 4) by the Verran \& Snyder-Halpern Sleep Scale analogue. The control group receives standard of care in the evenings and the same data as the intervention groups are collected for sleep quality and duration, pre-intervention and Time 1 and Time 2 ..

The differences in the scores for sleep quality and duration will be compared from pre-intervention to Time 1 and Time 2 for each group .

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Study Start: 2021-02-22
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

• Cognitive impairment .Allergy to lavender or grapeseed oil
• .Any condition that has been reported to affect the sense of smell
• Newly prescribed sleep medications (last two weeks prior to admission) or those causing sleepiness
• Pregnancy
• Currently using lavender therapy (aroma, massage, etc.).
• A smoker of any kind (tobacco, electronic cigarettes) .
• History of migraine headaches.
• Asthma, Bronchitis, or any airway disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
grapeseed oil	Grapeseed Oil	grapeseed oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown
lavender oil	lavender oil	lavender oil as aromatherapy two drops dispensed on a 2x2 gauze and pinned to subject's gown

Primary Outcome Measures

Name	Time	Method
Change in sleep duration from Baseline to Day 3 and day 4	Baseline, Day 3, Day 4	Measured by an increase in the mean scores Verans and Snyder-Halpern Sleep Scale (0-100) by 10 or greater
Change in sleep quality from Baseline to Day 3 and Day 4	Baseline Day 3, Day 4	Measured by an increase in mean scores on the the Verans and Snyder-Halpern Sleep Scale of 10 or greater

Trial Locations

Locations (2)

Northwell Health , South Shore University Hospital; 🇺🇸 Bay Shore, New York, United States

South Shore University Hosp; 🇺🇸 Bay Shore, New York, United States